ConsiGma™ Continuous Tableting Line: improved process control, higher tablet quality with higher process yield.

In line with the FDA initiative of 'quality by design' GEA Pharma Systems continues the introduction of the revolutionary ConsiGma™ continuous tableting line. The system satisfies the pharmaceutical industry’s demand for continuous production to provide improved quality, flexibility and consistency for pharmaceutical processes. As the only technology provider, GEA Pharma Systems presented the system at the FDA's first, Continuous Manufacturing Symposium March 11, 2010 in Bethesda, MD, USA.

One ConsiGma™ can run 500g in R&D, but can also run clinical trial, launch size, and any production size batches. There is no process scale-up as time is the only relevant factor in a continuous process. This allows manufacturers to reduce development time dramatically to reduce costs and bring products to market much faster.

Compact, modular construction with very short installation time
The system is compact (1/3 of a classic granulation line – inclusive of a Tablet Press), has a modular construction allowing it to fit perfectly into any R&D department or existing tablet production room. There’s no need to change the building, just wheel it in, connect the power and air supply, and after a simple start-up period it’s ready to go. Installation time and cost are reduced to a fraction of the current benchmark. It’s also possible to avoid high peak energy periods and run at continuous low energy consumption, helping companies meet their environmental obligations.

Consistent granule quality with improved compressibility characteristics
ConsiGma™ is capable of doing particle design and mimicking any traditional batch granulation process - with a much higher and consistent quality resulting from its continuous production set up and ‘risk based approach’ to GMP. The granules have generally a better intra-granular porosity with better compressibility characteristics that help tablet presses run more efficiently at maximum speed with hardly any weight adjustments being required.
 
The full tablet production line consists of the ConsiGma™ high shear granulator & dryer, combined with the GEA Courtoy MODUL™ P rotary tablet press. A special in-line blender mixes in the external phase between the systems.

The granulator and dryer section of the ConsiGma™ line has three modules: a wet high-shear granulation module, a segmented dryer module, and an evaluation module.

In the granulation module, dry ingredients are dosed, individually or premixed, in the continuous high-shear granulator. After a dry-mixing section, the granulation liquid is added, so each particle receives the same amount of liquid.

The dryer module, based on fluid-bed drying principles, splits the continuous flow of granules in packages of 1.5 kg, drying each of them in a separate segment of the dryer thereby guaranteeing plug-flow. When each segment is dry, it is emptied and transferred to the evaluation module and refilled with a new package of wet granules. The drying curve of each package is monitored, as a fingerprint of the process, and controlled to maintain a constant end humidity over the whole batch.

In the evaluation module the dried granules can be measured for critical quality attributes such as particle-size distribution, humidity, and content uniformity, using specially designed PAT tools.

The GEA Courtoy MODUL™ P rotary tablet press is based on the innovative Exchangeable Compression Module (ECM) concept. The ECM is completely isolated from the remainder of the machine, contains all product contact parts and can easlily be removed from the press in a contained way. This means that the press itself remains powder-free and requires no cleaning.
The 6 compression modes available in the MODUL™ P make it the perfect press for this continuous tableting line, allowing easy R&D and perfect production, with dual control for independent weight and hardness control and equal porosity tableting. The constant dwell time regardless of throughput fits perfectly in a continuous line, because it enables the press to change its speed when necessary (e.g. when a sample is taken in between drying and tableting).

With advanced in-line PAT incorporated in the system – GEA Pharma Systems can now provide a FULL continuous production line. One advanced process control system steers the whole line, including feedback and feedforward loops based on actual process values derived from o.a. GEA’s patented LighthouseProbe™ avoiding window fouling with an ingenious inline cleaning and recalibration system.

Learn more about ConsiGma™ Continuous Tableting Line at:
P-MEC India 2010, 01-03 December 2010, Stand: Hall 5. I 26

For further information contact GEA Pharma Systems India:

C. R. Dey
+91 (0) 265 3074 272

Ashul P. Jain
+91 (0) 265 3074 275

Navin Lakhanpaul
+91 (0) 265 3074 271
pharma-india@geagroup.com